Back to resultsThe Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
Primary Purpose
Schizophrenia, Psychotic Disorders, Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sibutramine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizoaffective disorder, schizophreniform disorder, bipolar I disorder
Eligibility Criteria
Eligibility Criteria: You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate. You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine. You must be able to visit the doctor's office as scheduled for the next 4 months. Exclusion Criteria: You have a history of an illness that would cause weight loss or gain in the near future. You have taken remoxipride within the past 6 months. You are allergic to olanzapine or Anti-obesity Agent. You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke. You have a serious medical illness, such as heart, liver, or kidney disease. You are pregnant or breast feeding.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044187
Brief Title
The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
Official Title
The Assessment of a Anti-Obesity Agent for the Treatment of Olanzapine-Associated Weight Gain in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder and Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.
The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders, Bipolar Disorder
Keywords
schizoaffective disorder, schizophreniform disorder, bipolar I disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sibutramine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Eligibility Criteria:
You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate.
You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine.
You must be able to visit the doctor's office as scheduled for the next 4 months.
Exclusion Criteria:
You have a history of an illness that would cause weight loss or gain in the near future.
You have taken remoxipride within the past 6 months.
You are allergic to olanzapine or Anti-obesity Agent.
You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.
You have a serious medical illness, such as heart, liver, or kidney disease.
You are pregnant or breast feeding.
Facility Information:
City
El Centro
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lafayette
State/Province
Indiana
Country
United States
City
Prairie Village
State/Province
Kansas
Country
United States
City
Milford
State/Province
Massachusetts
Country
United States
City
Clementon
State/Province
New Jersey
Country
United States
City
Beachwood
State/Province
Ohio
Country
United States
City
Johnson City
State/Province
Tennessee
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Bellevue
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
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